For decades, an annual gathering of oncologists has featured drug trials that were run mainly at American and European hospitals.
But at this year’s meeting, which was held in Chicago over the weekend, the signs are everywhere of China’s ascendance as a powerhouse in drug development — and of the threat that many believe it poses to American biotechnology.
The clearest sign: In what appears to be a first, one of the conference’s five coveted headliners was a presentation of a clinical trial conducted only in China.
That milestone at the meeting of the American Society of Clinical Oncology, or ASCO, reflects the dizzying growth of China’s biotechnology sector. In just a few years, it has transformed from a sleepy industry into a juggernaut rapidly inventing and testing cutting-edge medicines.
“This tells us that the Chinese biotech industry has arrived,” said Dr. Otis Brawley, a professor at Johns Hopkins who has attended the ASCO meeting every year since 1989.
But a growing contingent of U.S. officials, executives and doctors worry that the shift in drug innovation to China poses dangerous risks for research, American patients and biotech workers. They raise concerns about losing control over new medicines and about ceding America’s long-standing dominance in the field.
With Chinese companies churning out patents, papers in medical journals and new clinical trials, U.S. biotech startups say they are struggling to keep up and are facing deep disadvantages.
“I think the concerns are valid and very real,” said Dr. Robert Califf, a former commissioner of the Food and Drug Administration. “The U.S. is being seriously threatened.”
As tensions between Washington and Beijing have escalated, Democrats and Republicans have sounded the alarm about America’s reliance on China for generic drugs and raw materials.
Taking particular aim at China, President Donald Trump signed legislation that barred government agencies from contracting with certain foreign biotech service providers in adversarial countries. China’s surge into cutting-edge drug development introduces a new dimension of risk, critics say.
There is another worry. Will drugs work as well in American patients as they do in Chinese patients?
For reasons that researchers do not fully understand, Asian patients with lung cancer tend to live longer and respond better to immunotherapies than people of other ethnicities, according to some studies.
Yet China has a very high rate of smoking, and former smokers tend to fare worse when they get lung cancer. Further complicating the picture is differences in treatment — the cancer drugs typically used in China are often not the same as in the United States.
“In general, things look better in China,” said Dr. Peter Marks, who was a longtime FDA official before resigning last year. “It’s a fraught area right now. I think many of us have real concerns.”
Marks, who has since joined Eli Lilly as an executive overseeing its work on infectious diseases, stressed that he was not speaking for Lilly.
On the other side of the debate are those who warn that throttling competition from China would deprive Americans of new medicines. Ultimately, they say, the best data, no matter where it comes from, should win out.
In clinical trials, “patients either do well or they don’t, at the end of the day,” said Bob Duggan, a co-chief executive of Summit Therapeutics, based in Miami.
Summit bought the rights to the experimental drug from China, ivonescimab, that got top billing at ASCO. The company is testing the drug in separate studies in American patients, and is seeking to bring it to market in the United States and other parts of the world. The Chinese company that invented the drug, Akeso Biopharma, already sells it in China.
Its lung cancer study data, presented at ASCO’s plenary session, compared death rates in patients who received ivonescimab along with chemotherapy, compared with those who got standard treatment with chemotherapy and a drug that unleashes the immune system to fight the tumor. Those who got ivonescimab had a 34% lower death rate, according to the study published Sunday in the Lancet.
“It’s not a home run, but it’s not a loss,” said Dr. Roy Herbst, incoming director of the Dartmouth Cancer Center. The improvement, he added, was “incremental.”
China’s rising influence
In the last few years, the world’s biggest pharmaceutical companies have been filling their pipelines by turning to China, where prices are low, regulatory hurdles are fewer, and development timelines are quick.
So far this year, about half of such major deals involved a drug from China, up from next to nothing in the 2010s, according to DealForma, which tracks drug industry transactions.
That trend will be on vivid display at ASCO. Beyond ivonescimab, other presentations feature experimental cancer drugs invented and tested in China that have been scooped up by big drugmakers like Pfizer, Merck and Bristol Myers Squibb.
In particular, the drug bought by Merck impressed the field with results, announced earlier this month, showing it slowed tumor progression in Chinese patients with advanced lung cancer.
A Chinese company typically retains the rights to sell its drug in China. The big drugmakers buy the U.S. rights, spurning offerings from American startups that are developing similar medicines.
Critics of China also point to an increasingly worrisome pattern. Chinese drug developers race to essentially copy U.S. inventions. As protection, some U.S. biotech startups have imposed new measures to maintain secrecy, like refusing to publish papers or present posters at conferences.
For now, big multinational pharmaceutical companies are developing most drugs invented in China for introduction to the U.S. market. But some fear that if more Chinese companies assume a direct role, American patients could become dangerously reliant on the Chinese government for access to vital brand-name drugs.
There is a risk, Marks said, of “creating a new Strait of Hormuz.”
Rep. John Moolenaar, R-Mich., has called for prohibiting the FDA from reviewing data from China and curbing the dealmaking between major U.S. drugmakers and Chinese companies. But his proposals have not gained much traction.